Asensus Surgical, Inc. (NYSE American: ASXC), a medical device
company that is digitizing the interface between the surgeon and
the patient to pioneer a new era of Performance-Guided Surgery™,
today provided a preliminary 2021 year-end corporate update.
Fourth Quarter Highlights
- Over 500 procedures were performed globally during the quarter,
representing growth of over 25% over the fourth quarter 2020
- Six Senhance Surgical Programs were initiated during the
quarter, including two previously unannounced programs in Germany
and Ukraine
Year-End Highlights
- Over 2,000 procedures were performed globally, representing
growth of over 42% compared to 2020
- In 2021, 10 Senhance Surgical Programs were initiated
- Received four regulatory clearances:
- FDA 510(k) clearance for expansion of Machine Vision
Capabilities for the Intelligent Surgical Unit™ (ISU™)
- FDA 510(k) clearance for articulating instruments
- Expanded FDA 510(k) clearance for general surgery
indication
- CE Mark approval for the ISU
- The Company had unaudited cash, cash equivalents, short-term
and long-term investments, excluding restricted cash, of
approximately $135.8 million at December 31, 2021
- Fourth quarter unaudited revenue is expected to be
approximately $2.1 - $2.5 million
- Full year 2021 unaudited revenue is expected to be
approximately $7.9 - $8.3 million, representing growth of 147%
-159% over the prior year
"Digital transformation is occurring in many sectors and it’s a
critical time to bring it to the OR to elevate surgery in ways that
matter. Last year was a strong one for the company as we continued
to empower surgeons around the globe with new tools and Clinical
Intelligence for increased control, less variability, and
consistently superior outcomes. Driving greater than 42% growth in
global Senhance procedure volumes and initiating ten new Senhance
programs is encouraging and points to the continued growing demand
for Senhance and the clinical utility it delivers to surgeons and
hospitals,” said Anthony Fernando, Asensus Surgical President and
CEO. “We look forward to leveraging the momentum we generated to
accelerate adoption of Senhance and continuing to make progress on
the promise of Performance-Guided Surgery."
Market Development
2021 Senhance Program Initiations Throughout 2021, the Company
initiated 10 Senhance Surgical Program initiations: one in the US,
six in EMEA, and three in Asia.
During the fourth quarter of 2021, the Company initiated six
programs, one in the US, three in EMEA, and two in Asia. Included
in this are two previously unannounced program initiations which
occurred in December of 2021, at hospitals in Germany and Ukraine,
respectively.
Procedure Volumes In 2021, surgeons performed over 2,000
procedures utilizing the Senhance System, representing a 42%
increase over the previous year. Compared to 2020, US-based
procedure volumes increased over 90%, Asia procedure volumes
increased 14%, and EMEA increased over 42%. These procedures
included general surgery, gynecology, urology, colorectal,
pediatric, and bariatric surgical cases.
Clinical Validation
During 2021, there were 21 peer-reviewed clinical papers
published providing further support for the clinical utility of the
Senhance System across a variety of surgical specialties. In
particular, there were four milestone papers published:
- In April, a study was published comparing health economic
outcomes of the Senhance System versus another robotic system, as
well as traditional laparoscopy. According to the study, the
Senhance System was less than half the median instrument cost
compared to procedures performed on another robotic platform and
was comparable to traditional laparoscopic-assisted vaginal
hysterectomy costs for certain gynecologic procedures.
- In May, a study was published which analyzed the outcomes of
over 800 Senhance System procedures across multiple specialties
including hernia repairs, cholecystectomies, and prostatectomies
based on data from the Company’s real-world clinical data registry,
TRUST. According to the study, Senhance System procedures are safe
and reproducible and deliver promising clinical outcomes.
- In August, a study was published which analyzed the outcomes
and experience of utilizing the Senhance System to perform a high
volume of urologic procedures. According to the study, the Senhance
System is a safe and feasible platform to perform multiple common
urologic procedures, namely upper urinary tract and extraperitoneal
radical prostatectomies.
- In September, a study was published which analyzed the outcomes
of inguinal hernia repair procedures based on data from the
Company’s TRUST registry. According to the study, the Senhance
System is a safe and doable platform to perform inguinal hernia
repair procedures, and it can deliver high quality clinical
outcomes related to patient recovery time, length of hospital stay,
and postoperative pain.
Portfolio Expansion
Performance-Guided Surgery (PGS) PGS builds upon the foundation
of Digital Laparoscopy by adding machine vision, augmented
intelligence, and deep learning capabilities to help guide improved
decision making, enriched collaboration, and enhanced
predictability for all surgeons, independent of training or
experience, to shift the promise of consistently superior surgery
into practice.
Historical advances in surgery have largely focused on bringing
tools and techniques into the OR to reduce the invasiveness of
procedures and improve the execution of discrete tasks. Unlike many
other industries, very little focus has been on improving the
decision-making aspects of the surgical process, which is crucial
in the high-pressure, highly variable situations which happen
repeatedly during any surgery.
PGS is the first surgical paradigm focused on a holistic
solution for the entire surgeon workflow to drive consistently
superior outcomes. We believe PGS can deliver real-time clinical
decision support to boost surgeon capabilities to perceive complex
environments, make decisions, and perform the desired tasks with
increased precision, safety, and efficiency to mitigate surgical
errors and complications.
Expanded Global ISU Machine Vision Capabilities In September,
the Company announced that it had received 510(k) clearance from
the FDA for an expansion of machine vision capabilities on the
previously cleared ISU. The ISU is utilized with the Senhance
System which enables Digital Laparoscopy. The initial features of
the ISU enable machine vision-driven control of the camera for a
surgeon by responding to commands and recognizing certain objects
and locations in the surgical field, and allow a surgeon to change
the visualized field of view using the movement of their
instruments. The newest ISU features expanded upon these
capabilities and introduced more advanced features including:
real-time 3D measurement, digital tagging, image enhancement, and
enhanced camera control based on real-time data from anatomical
structures while performing surgery. This is the first time any of
these features will be clinically available in soft-tissue
abdominal surgery.
Articulating Instrument Clearance In July, the Company announced
that it had received 510(k) clearance for 5 mm articulating
instruments, which offer better access to difficult-to-reach areas
of the anatomy.
General Surgery Indication Expansion In March, the Company
announced that it had received an additional FDA clearance for the
Senhance Surgical System which allows for indication expansion in
general surgery in the US.
CE Mark for Intelligent Surgical Unit In January, the Company
announced that it had received CE Mark approval for the ISU that
enables machine vision capabilities on the Senhance System. This
approval will provide Senhance Digital Laparoscopy programs in
Europe access to this technology.
Fourth Quarter and Full Year 2021 Revenue
For the quarter ended December 31, 2021, the Company estimates
preliminary unaudited revenue of approximately $2.1 - $2.5 million.
For the full year, preliminary unaudited 2021 revenue is expected
to be approximately $7.9 - $8.3 million, representing revenues from
the sale of three Senhance Systems, system leasing, and related
revenues from instruments and accessories, and services.
Balance Sheet
As of December 31, 2021, the Company had preliminary unaudited
cash, cash equivalents, short-term and long-term investments,
excluding restricted cash, of approximately $135.8 million, and
there were approximately 235.2 million shares of common stock
outstanding.
About Asensus Surgical, Inc.
Asensus Surgical, Inc. is digitizing the interface between the
surgeon and patient to pioneer a new era of Performance-Guided
Surgery by unlocking clinical intelligence for surgeons to enable
consistently superior outcomes and a new standard of surgery. This
builds upon the foundation of Digital Laparoscopy with the Senhance
Surgical System powered by the Intelligent Surgical Unit (ISU) to
increase surgeon control and reduce surgical variability. With the
addition of machine vision, augmented intelligence, and deep
learning capabilities throughout the surgical experience, we intend
to holistically address the current clinical, cognitive and
economic shortcomings that drive surgical outcomes and value-based
healthcare. Learn more about Performance-Guided Surgery and Digital
Laparoscopy with the Senhance Surgical System here:
www.senhance.com. Now available for sale in the US, EU, Japan,
Russia, and select other countries. For a complete list of
indications for use, visit: www.senhance.com/indications. For more
information, visit www.asensus.com.
Forward-Looking Statements
This press release includes statements relating to the Senhance
System and our preliminary 2021 results. These statements and other
statements regarding our future plans and goals constitute "forward
looking statements" within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934, and are intended to qualify for the safe harbor from
liability established by the Private Securities Litigation Reform
Act of 1995. Such statements are subject to risks and uncertainties
that are often difficult to predict, are beyond our control and
which may cause results to differ materially from expectations and
include whether we will be able to continue to progress our
strategic plan in 2022; whether final 2021 fourth quarter and full
year revenue will meet expectations; whether the momentum we have
generated will drive accelerated adoption of the Senhance System
and whether we will continue to make progress towards on the
promise of Performance-Guided Surgery; whether Performance Guided
Surgery can deliver real-time clinical decision support to boost
surgeon capabilities to perceive complex environments, make
decisions, and perform the desired tasks with increased precision,
safety, and efficiency to mitigate surgical errors and
complications; whether we can continue to increase Senhance System
placements and sales, and whether we can continue to add
foundational sites and receive regulatory clearances and approvals
that we seek. For a discussion of the risks and uncertainties
associated with the Company’s business, please review our filings
with the Securities and Exchange Commission (SEC). You are
cautioned not to place undue reliance on these forward-looking
statements, which are based on our expectations as of the date of
this press release and speak only as of the origination date of
this press release. We undertake no obligation to publicly update
or revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20220110005256/en/
INVESTOR CONTACT: Mark Klausner or Mike Vallie,
443-213-0499 invest@asensus.com or MEDIA CONTACT: Kristin
Schaeffer, 858-354-8850 CG Life kschaeffer@cglife.com
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